Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patients
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/06/025999
- Lead Sponsor
- BVG Life Sciences Ltd
- Brief Summary
The coronavirus disease 2019 (COVID-19) is a global pandemic. Presently there is a quest of an
appropriate treatment which could arrest the fatality of the disease and also enhance the recovery
rate of the affected individuals. With years of rigorous R&D, BVG has developed ShatPlus
formulation, having immune-modulatory, anti-viral, immune-stimulant, anti-inflammatory and
anti-oxidant effects studied through scientific validation. The Ayurvedic ingredients used in the
above formulation are scientifically reported to have anti-viral effects. BVG Life Sciences Limited
herewith has planned clinical trial to clinical validate “ShatPlusâ€, an ayurvedic proprietary
medicine against COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Patients admitted with RT-PCR confirmed COVID-19 illness.
- Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8) Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.
Pregnant women Breastfeeding women Requiring ICU admission at screening Patients above 65 years of age and below 18 Years Past History of MI, Epileptic episodes Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening Any other condition by which subject proves unfit from investigator perspective Not giving consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19 Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study
- Secondary Outcome Measures
Name Time Method Change in National Early Warning Score Hematological parameters like WBS, HB and platelet count etc.
Trial Locations
- Locations (1)
Pimpri Chinchwad Municipal Corporatios YCM Hospital
🇮🇳Pune, MAHARASHTRA, India
Pimpri Chinchwad Municipal Corporatios YCM Hospital🇮🇳Pune, MAHARASHTRA, IndiaDr Tushar V PatilPrincipal investigator8888844203tvpatil71@gmail.com